Hepatotoxicity

Severe, life-threatening,
and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has
been reported in patients treated with VIRAMUNE. In some cases, patients
presented with non-specific prodromal signs or symptoms of hepatitis and
progressed to hepatic failure. These events are often associated with rash.
Female gender and higher CD4+ cell counts at initiation of therapy
place patients at increased risk; women with CD4+ cell counts
greater than 250 cells/mm³ , including pregnant women receiving
VIRAMUNE in combination with other antiretrovirals for the treatment of HIV-1
infection, are at the greatest risk. However, hepatotoxicity associated with
VIRAMUNE use can occur in both genders, all CD4+ cell counts and at
any time during treatment. Hepatic failure has also been reported in patients
without HIV taking VIRAMUNE for post-exposure prophylaxis (PEP). Use of
VIRAMUNE for occupational and non-occupational PEP is contraindicated [see CONTRAINDICATIONS].
Patients with signs or symptoms of hepatitis, or with increased transaminases
combined with rash or other systemic symptoms, must discontinue VIRAMUNE and
seek medical evaluation immediately [see WARNINGS AND PRECAUTIONS].

Skin Reactions

Severe, life-threatening
skin reactions, including fatal cases, have occurred in patients treated with
VIRAMUNE. These have included cases of Stevens-Johnson syndrome, toxic
epidermal necrolysis, and hypersensitivity reactions characterized by rash,
constitutional findings, and organ dysfunction. Patients developing signs or
symptoms of severe skin reactions or hypersensitivity reactions must
discontinue VIRAMUNE and seek medical evaluation immediately. Transaminase
levels should be checked immediately for all patients who develop a rash in the
first 18 weeks of treatment. The 14-day lead-in period with VIRAMUNE 200 mg
daily dosing has been observed to decrease the incidence of rash and must be
followed [see WARNINGS AND PRECAUTIONS].

Monitoring

Patients must be monitored
intensively during the first 18 weeks of therapy with VIRAMUNE to detect
potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance
is warranted during the first 6 weeks of therapy, which is the period of
greatest risk of these events. Do not restart VIRAMUNE following clinical
hepatitis, or transaminase elevations combined with rash or other systemic
symptoms, or following severe skin rash or hypersensitivity reactions. In some
cases, hepatic injury has progressed despite discontinuation of treatment.

DRUG DESCRIPTION

VIRAMUNE is the brand name for nevirapine, a
non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against
Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a
member of the dipyridodiazepinone chemical class of compounds.

The chemical name of nevirapine is
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4]
diazepin-6-one. Nevirapine is a white to off-white crystalline powder with the
molecular weight of 266.30 and the molecular formula C15H14N4O.
Nevirapine has the following structural formula:

What are the possible side effects of nevirapine (Viramune, Viramune XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: tired feeling, joint or muscle pain, muscle weakness, skin rash, bruising, severe tingling, numbness, mouth sores, trouble breathing, or swelling of your face, lips, tongue, or throat.

Stop taking nevirapine and call your doctor at once if you have a serious side effect such as:

What are the precautions when taking nevirapine (Viramune)?

Before taking nevirapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Rarely, this drug may make some people drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now...